HTO Nevada recalls Maximum Zone:2 Topical Analgesic 1oz bottles for discoloration of epinephrine ingredient, affecting licensed professionals. Stop using immediately if you have the product.
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
HTO Nevada is recalling Maximum Zone2 Topical Analgesic 1oz bottles because the epinephrine ingredient was discolorated during manufacturing. This could affect licensed professionals using the product for pain-sensitive procedures.
The epinephrine ingredient in the product was discolorated due to a manufacturing deviation. This discoloration may indicate a quality issue that could affect the product's safety and effectiveness for medical use.
Licensed professionals who use Maximum Zone2 Topical Analgesic for pain-sensitive procedures are most at risk. The recall applies to specific product lots distributed by DERMAL SOURCE.
Check for the product name 'Maximum Zone2 Topical Analgesic', 1oz bottle, and lot number 795CP-0003. It was distributed by DERMAL SOURCE and sold with NDC code 80069-012-01.
Look for the lot number 795CP-0003 on the product label to confirm if it's affected.
The recall states the epinephrine ingredient was discolorated, but the official notice does not specify if the product is safe to use after the discoloration.
The recall record does not mention any remedy or replacement options.
The recall record does not specify a contact for help, though DERMAL SOURCE is listed as the distributor.
We’ve drafted a message you can send HTO Nevada to request your refund or repair — edit it as you like.
Subject: Recall D-0271-2023 — HTO Nevada HTO Nevada Hello, I own a HTO Nevada that is covered by recall D-0271-2023 from HTO Nevada. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
